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NCT00520364 · ClinicalTrials.gov registry record
In Vitro Fertilization and Pregnancy After Use of Chemotherapy
A clinical trial, sponsored by New York Medical College.
- Terminated
- Registry status
- 100
- Enrollment target
NCT00520364: Clinical Trial study, sponsored by New York Medical College.
NCT00520364 is a clinical trial that was terminated before completion, run by New York Medical College. The registered enrollment target is 100 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00520364 was terminated before completion, sponsored by New York Medical College.
- TERMINATED
- Registry status
- 100 participants
- Enrollment target
Study Summary
Objective: Chemotherapy regimens containing alkylating agents result in primordial follicle death and premature ovarian failure. Depending on the age and the type/dose of chemotherapy, some women may continue to menstruate. Our aim was to ascertain the impact of chemotherapy on ovarian reserve in patients who previously received chemotherapy by response to controlled ovarian hyper stimulation (COH) and anti-mullerian hormone (AMH) levels. Design: Prospective study with retrospective controls Materials and Methods: 45 cancer patients underwent controlled ovarian stimulation for IVF before (30 patients, 30 IVF cycles) or after (15 patients, 30 IVF cycles) chemotherapy. Patients with basal serum FSH \>13mIU/mL or E2\>70pg/ml were excluded. AMH was measured on previously stored serum samples from the day of initiation of the ovarian stimulation. Results: Mean ages and baseline FSH levels of pre- and postchemotherapy IVF patients were similar (36.8±0.91 vs. 36.3±1). The mean interval from completion of chemotherapy to IVF was 8.03±1.32 years (range 1-23). Of the 30 IVF cycles in post-chemotherapy patients, 22 received alkylating agents and 8 did not. There were no significant differences between the study and control cycles regarding day-2 estradiol (E2), length of stimulation, total gonadotropin dose, and E2 on hCG day (table 2). Cycle cancellation rate was 20% and 26.67% for pre and post-chemotherapy patients, respectively. The number of oocytes retrieved and fertilized were significantly higher in pre-chemotherapy group (p\<0.0001). Two clinical pregnancies were achieved in the postchemotherapy group, one ending in spontaneous abortion and the other in the delivery of a healthy baby (6.67% clinical pregnancy rate and 3.33% delivery rate per attempted cycle). All fertilized oocytes in the control group were cryopreserved at 2-pronuclei stage. Baseline AMH levels were significantly lower in post chemotherapy IVF patients compared to those who underwent IVF prior to ch
Interventions
- OTHER Observation of IVF outcomes in relation to chemo history and AMH
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2014-09-15 |
| Est. Completion | 2018-05-30 |
Why NCT00520364 stopped before completion
NCT00520364 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Observation of IVF outcomes in relation to chemo history and AMH is the first listed.
NCT00520364 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00520364 about?
NCT00520364 is a clinical study titled "In Vitro Fertilization and Pregnancy After Use of Chemotherapy". Objective: Chemotherapy regimens containing alkylating agents result in primordial follicle death and premature ovarian failure. Depending on the age and the type/dose of chemotherapy, some women may continue to menstruate. Our aim was to ascertain the impact of chemotherapy on ovarian reserve in pa...
What is the current status of trial NCT00520364?
This trial is currently terminated. The enrollment target is 100 participants. The study started on 2014-09-15. Estimated completion is 2018-05-30.
What interventions are being tested in trial NCT00520364?
The interventions under investigation include: Observation of IVF outcomes in relation to chemo history and AMH (OTHER).
Who is sponsoring clinical trial NCT00520364?
This trial is sponsored by New York Medical College, which has 47 total clinical trials registered on ClinicalTrials.gov.
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